The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.

General Quality of Life [ Time Frame: PreTreatment, 6 Months and 12 Months After Treatment ] [ Designated as safety issue: No ]

The SF-12 Quality of Life questionnaire will be used to assess general health status. The SF-12 contains one or two items that measure each of eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).

Speech analysis will focus primarily on speech intelligibilty and acceptability to both clinicians and naive listeners, and less on voice quality per se using the Voice Handicap Index. The Voice Handicap Index (VHI) measures the influence of voice problems on a patient's quality of life.

Head and Neck Quality of Life [ Time Frame: PreTreatment, 6 Months and 12 Month After Treatment ] [ Designated as safety issue: No ]

The University of Washington Quality of Life Assessment Questionnaire will be administered. This questionnaire is specifically designed to capture head and neck cancer-specific function.

Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.

Patients Treated with Chemoradiation

Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.

Detailed Description:

At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.

Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.

Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Newly diagnosed squamous cell carcinoma of the larynx (cartilage invading-T3 and all T4) or hypopharynx (T2 and T3) for which curative treatment is planned. The tumor must be resectable with total laryngectomy alone as determined by the treating surgeon - this requirement is regardless of whether the surgery of chemoradiation is planned for the patient.

Criteria

Inclusion Criteria:

Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team

Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Must be at least 18 years of age

Exclusion Criteria:

Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy)

Undergo partial laryngectomy, when open or endoscopic

Have previously altered anatomy of the upper aerodigestive tract

Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents)

Have prior malignant disease of the upper aerodigestive tract

Have prior radiation therapy to the head and neck region

Metastatic disease

Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089803

Locations

United States, Minnesota

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

American Academy of Otolaryngology-Head and Neck Surgery Foundation

American Head and Neck Society

Investigators

Principal Investigator:

Bevan Yueh, MD, MPH

Masonic Cancer Center, University of Minnesota

More Information

Responsible Party:

University of Minnesota - Clinical and Translational Science Institute